Bill Text: MI SB0553 | 2011-2012 | 96th Legislature | Introduced
Bill Title: Insurance; health; coverage for off-label use of approved drugs; modify. Amends sec. 3406q of 1956 PA 218 (MCL 500.3406q).
Spectrum: Partisan Bill (Republican 1-0)
Status: (Introduced - Dead) 2011-06-30 - Referred To Committee On Insurance [SB0553 Detail]
Download: Michigan-2011-SB0553-Introduced.html
SENATE BILL No. 553
June 30, 2011, Introduced by Senator CASPERSON and referred to the Committee on Insurance.
A bill to amend 1956 PA 218, entitled
"The insurance code of 1956,"
by amending section 3406q (MCL 500.3406q), as amended by 2003 PA
88.
THE PEOPLE OF THE STATE OF MICHIGAN ENACT:
Sec. 3406q. (1) An expense-incurred hospital, medical, or
surgical policy or certificate delivered, issued for delivery, or
renewed in this state that provides pharmaceutical coverage and a
health maintenance organization contract that provides
pharmaceutical coverage shall provide coverage for an off-label use
of a federal food and drug administration approved drug and the
reasonable cost of supplies medically necessary to administer the
drug.
(2) Coverage for a drug under subsection (1) applies if all of
the following conditions are met:
(a) The drug is approved by the federal food and drug
administration.
(b) The drug is prescribed by an allopathic or osteopathic
physician for the treatment of either of the following:
(i) A life-threatening condition so long as the drug is
medically necessary to treat that condition and the drug is on the
plan formulary or accessible through the health plan's formulary
procedures.
(ii) A chronic and seriously debilitating condition so long as
the drug is medically necessary to treat that condition and the
drug is on the plan formulary or accessible through the health
plan's formulary procedures.
(c) The drug has been recognized for treatment for the
condition for which it is prescribed by 1 of the following:
(i) The American medical association drug evaluations.
(ii) The American hospital formulary service drug
information.
(iii) The United States pharmacopoeia dispensing
information,
volume
1, "drug information for the health care professional".
(i) (iv) Two Except
as otherwise provided in subparagraph (ii), 2
articles from major peer-reviewed medical journals that present
data supporting the proposed off-label use or uses as generally
safe and effective unless there is clear and convincing
contradictory evidence presented in a major peer-reviewed medical
journal.
(ii) For cancer treatment, 2 articles from major peer-reviewed
medical journals recognized by the centers for medicare and
medicaid services that present data supporting the proposed off-
label use or uses as generally safe and effective unless there is
clear and convincing contradictory evidence presented in a major
peer-reviewed medical journal.
(iii) The American hospital formulary service drug information.
(iv) National comprehensive cancer network drugs and biologics
compendium.
(v) Thomson Reuters micromedex drugdex.
(vi) Clinical pharmacology.
(vii) Other authoritative compendia as identified by the
secretary of the United States department of health and human
services and as certified by the commissioner.
(3) Upon request, the prescribing allopathic or osteopathic
physician shall supply to the insurer or health maintenance
organization documentation supporting compliance with subsection
(2).
(4) This section does not prohibit the use of a copayment,
deductible, sanction, or a mechanism for appropriately controlling
the utilization of a drug that is prescribed for a use different
from the use for which the drug has been approved by the federal
food and drug administration. This may include prior approval or a
drug utilization review program. Any copayment, deductible,
sanction, prior approval, drug utilization review program, or
mechanism described in this subsection shall not be more
restrictive than for prescription coverage generally.
(5) As used in this section:
(a) "Chronic and seriously debilitating" means a disease or
condition that requires ongoing treatment to maintain remission or
prevent deterioration and that causes significant long-term
morbidity.
(b) "Life-threatening" means a disease or condition where the
likelihood of death is high unless the course of the disease is
interrupted or that has a potentially fatal outcome where the end
point of clinical intervention is survival.
(c) "Off-label" means the use of a drug for clinical
indications other than those stated in the labeling approved by the
federal food and drug administration.
